BridgeMD
A trial funded by the German Federal Ministry for Education and Research (BMBF) to evaluate the effects of closed-loop automatic control of inspiratory fraction of oxygen in comparison to manual control in extremly preterm infants with respect to complications of prematurity potentially related to inadequate administration of oxygen (ROP, NEC, BPD) and mortality as well as the neurocognitive outcome after 24 months
EU CTIS ID: 2024-511335-10-01
What this study is testing
To assess the effect of efficacy of closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C) provided in standard infant ventilators in addition to manual adjustments of the inspired oxygen fraction (FiO2) during mechanical ventilation, continous positive airway pressure (CPAP) or any other positive pressure respiratory support compared to manual adjustments of the FiO2 only on the primary enpoints.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- GA at birth 23+0/7 to 27+6/7 weeks
You likely can't join if
- Decision not to provide full life support / decision for palliative care only before study entry
- Severe congenital abnormalities (particularly those affecting respiratory, cardiovascular, or gastrointestinal function or long-term neuro-cognitive development, whereas a patent ductus arteriosus or a PFO/ASDII is not considered a congenital anomaly in preterm infants)
- Postnatal age >48h
- Lack of device enabling closed-loop automatic control of FiO2 before randomization
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.